Study On The Preparation And Quality Standard And Stability Of Waishangruyi Gel

Waishangruyi gel is a gel preparation based on transform of the dosage form of waishangruyi paste. The formula compose of cape jasmine fruit, radix et rhizoma rhei, lithospermi, garden burnet root, baical skullcap roo, amoorcorn tree bark and borneo camphor. It has the functions of alleviating fever and detoxification, cooling blood to dispel the silt, controlling swelling and pain, stop bleeding and promote tissue regeneration. Now there are no factories to produce waishangruyi gel preparation, so it is practice to reform the waishangruyi paste to gel preparation.Waishangruyi gel whose preparation, quality standard and stability have been studied in this project.An orthogonal experiment design was used to measure the best produce progress. Three batch of the samples were repeated to prove the extract method was stable and reliable. Ethanol sediments method was conformed by single factor experiment design. After the exeriment on sort and dosage of matrix and ration, the preparation method of waishangruyi gel was determined finally.Cape jasmine fruit, radix et rhizoma rhei,lithospermi, baical skullcap root, amoorcorn tree bark and borneo camphor were identificated separated and their TLC identification methods and the method used to control the component of the jasminoidin were formed. Results showed that this method is concise. This new quality standard were improved more than origin.Three batch pilot scale product samples in the package of finished products were observed in room temperature for 12 months and holed on a accelerated test for 6 months. The results showed all batch samples correspond to the quality standard and the test of microbial limitation.